Advanced Immune Support [Discontinued] by The Vitamin Shoppe

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. It is unclear if oral AHCC is beneficial in patients with cancer. Details: Although some small clinical studies in patients with gastric or colon cancer have found that patients taking AHCC 3-6 grams daily have better survival rates and quality of life when compared with historical population data, other observational research has not found a benefit for patients with head, neck, lung, or breast cancer when compared with baseline (30421,30425,30454). The validity of these studies is limited by lack of a comparator group.
• Chemotherapy-induced anemia. It is unclear if oral AHCC is beneficial in patients with chemotherapy-induced anemia. Details: A small clinical study in adults receiving chemotherapy for pancreatic cancer shows that taking AHCC 6 grams daily for 8-12 weeks does not reduce the rate of grade 2 to 3 anemia when compared with placebo (110131).
• Chemotherapy-induced leukopenia. It is unclear if oral AHCC is beneficial in patients with chemotherapy-induced leukopenia. Details: Preliminary clinical research in patients with breast cancer receiving chemotherapy shows that taking AHCC significantly reduces chemotherapy-related neutrophil events and lipid abnormalities when compared with standard care (94829).Observational research in patients with resectable pancreatic ductal adenocarcinoma has found that taking AHCC orally 3 grams daily throughout 2 cycles of neoadjuvant gemcitabine improves the neutrophil-to-lymphocyte ratio and nutritional scores when compared with standard of care (106783). In contrast, other clinical research in patients with pancreatic or biliary tract cancer receiving gemcitabine chemotherapy shows that taking AHCC 6 grams daily for two months does not seem to affect neutropenia, thrombocytopenia, or hepatic dysfunction when compared with standard of care. However, taking AHCC did reduce C-reactive protein and increase hemoglobin and albumin when compared to standard of care (30424).
• Chemotherapy-induced nausea and vomiting (CINV). It is unclear if oral AHCC is beneficial in patients with CINV. Details: Preliminary clinical research in patients being treated for head and neck cancers shows that taking AHCC 3 grams daily, beginning 3 days prior to chemotherapy and continuing until one week after chemotherapy, reduces gastric side effects and the need for antiemetic therapy when compared with baseline (30425). The validity of these findings is limited by the lack of a comparator group.
• Chemotherapy-induced taste changes. It is unclear if oral AHCC is beneficial for the prevention of taste changes due to chemotherapy. Details: A small clinical study in adults receiving chemotherapy for pancreatic cancer shows that taking AHCC 6 grams daily for 8-12 weeks reduces the rate of patient-reported taste disorders by 27% when compared with placebo (110131). Although patients in the AHCC group had modest improvements in some nutritional parameters when compared with the placebo group, it is unclear if any changes would be considered clinically significant.
• Hepatitis C. It is unclear if oral AHCC is beneficial in patients with hepatitis C. Details: Preliminary clinical research in adults with chronic hepatitis C shows that taking AHCC 6 grams daily for 6 months does not significantly reduce alanine aminotransferase (ALT) or hepatitis C virus RNA levels when compared with placebo (30419).
• Human papillomavirus (HPV). It is unclear of oral AHCC is beneficial in patients with HPV. Details: A small clinical study in adult females with persistent high-risk HPV shows that taking AHCC 3 grams daily leads to clearance of HPV RNA and DNA in 64% of patients after 6 months of treatment, compared to 11% of patients taking placebo (110129). The validity of these findings is limited by lack of statistical comparison between groups.
• Liver cancer. Small, low-quality clinical studies suggest that oral AHCC may improve overall survival in patients with liver cancer. Details: Preliminary clinical research in patients with advanced hepatic cancer shows that taking AHCC orally 6 grams daily for a median of 3.5 months along with supportive care increases the median survival time by 2 months when compared with placebo. Taking AHCC also improved quality of life scores when compared with placebo (30359). Population research in patients with hepatocellular carcinoma has also found that taking AHCC 3 grams daily for up to 9 years after surgical resection reduces tumor recurrence and mortality by 48% and 56%, respectively, when compared with control (30353). In another small, open label clinical study of adults with advanced hepatocellular carcinoma, tumor recurrence occurred in 52% of patients who took AHCC 1 gram three times daily for 2 years after surgical resection (110130). The interpretation of these results is limited by the lack of a control group.
• Prostate cancer. Although there has been interest in using oral AHCC for prostate cancer, there is insufficient reliable information about the clinical effects of AHCC for this purpose. More evidence is needed to rate AHCC for these uses.

(Read more about ACTIVE HEXOSE CORRELATED COMPOUND (AHCC))

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). Oral agaricus mushroom has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in people with IgE-positive birch pollen allergy shows that taking a specific agaricus mushroom product (Andosan, Immunopharma) containing 82% agaricus mushroom, 15% Hericium erinaceus mushroom, and 3% maitake mushroom extracts, 60 mL daily for 7 weeks starting before the pollen season, reduces symptoms of allergic rhinitis and allergic asthma and decreases use of anti-allergy medications when compared with placebo. During the allergy season, birch-specific IgE levels were reduced, and basophils were less sensitive to allergen activation (102919).
• Cancer. Although there is interest in using oral agaricus mushroom for the treatment of various types of cancer, there is insufficient reliable information about the clinical effects of agaricus mushroom for this purpose. Cardiovascular disease (CVD).Although there is interest in using oral agaricus mushroom for the management of CVD and CVD risk factors, there is insufficient reliable information about the clinical effects of agaricus mushroom for this purpose.
• Chemotherapy-induced adverse effects. It is unclear if oral agaricus mushroom is beneficial for reducing adverse effects in patients undergoing chemotherapy treatment. Details: Preliminary clinical research in females with gynecologic cancers shows that taking an agaricus mushroom extract three times daily while receiving chemotherapy for 6 weeks might improve some of the adverse effects of chemotherapy, such as generalized weakness, decreased appetite, and emotional instability, when compared with chemotherapy alone (15404).
• Crohn Disease. It is unclear if oral agaricus mushroom is beneficial for Crohn disease. Details: Preliminary clinical research in patients with Crohn disease shows that taking an oral agaricus mushroom extract (AndoSan, ACE Co. Ltd.) 30 mL twice daily for 21 days does not improve fatigue, quality of life, or symptom severity when compared with placebo (94721).
• Diabetes. It is unclear if oral agaricus mushroom is beneficial for type 2 diabetes. Details: Preliminary clinical research in patients with type 2 diabetes shows that taking an agaricus mushroom extract 500 mg orally three times daily for 12 weeks, in combination with metformin and the sulfonylurea gliclazide, decreases insulin resistance and lowers fasting insulin levels more than metformin and gliclazide alone (15421).
• Hepatitis B. It is unclear if oral agaricus mushroom is beneficial for hepatitis B. Details: Preliminary clinical research in adults with chronic hepatitis B infection shows that taking agaricus mushroom extract 500 mg three times daily for 12 months decreases aspartate aminotransferase (AST) from 246 IU/L to 61 IU/L and alanine aminotransferase (ALT) from 151 IU/L to 46 IU/L (94719). However, these results are limited by small study size and the lack of a comparator group.
• Hyperlipidemia. Although there is interest in using oral agaricus mushroom for hyperlipidemia, there is insufficient reliable information about the clinical effects of agaricus mushroom for this condition.
• Multiple myeloma. It is unclear if oral agaricus mushroom is beneficial for multiple myeloma. Details: Preliminary clinical research in patients with multiple myeloma undergoing stem cell transplantation with high-dose chemotherapy shows that taking an agaricus mushroom extract (AndoSan, ACE Co. Ltd.) 60 mL orally daily for about 7 weeks during chemotherapy does not improve treatment response or overall survival when compared with placebo (94716).
• Osteoporosis. Although there is interest in using oral agaricus mushroom for osteoporosis, there is insufficient reliable information about the clinical effects of agaricus mushroom for this condition.
• Peptic ulcers. Although there is interest in using oral agaricus mushroom for peptic ulcers, there is insufficient reliable information about the clinical effects of agaricus mushroom for this condition.
• Ulcerative colitis. It is unclear if oral agaricus mushroom is beneficial for ulcerative colitis. Details: Preliminary clinical research in patients with symptomatic ulcerative colitis shows that taking an agaricus mushroom extract (AndoSan, ACE Co. Ltd.) 30 mL orally twice daily for 21 days improves fatigue, quality of life, and overall symptom scores when compared with placebo (94715). More evidence is needed to rate agaricus mushroom for these uses.

(Read more about AGARICUS MUSHROOM)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). It is unclear if oral astragalus is beneficial for allergic rhinitis. Details: Preliminary clinical research shows that taking a specific astragalus root extract standardized to contain 40% polysaccharides (Lectranal, Milsing d.o.o.) 160 mg orally twice daily for 3-6 weeks improves symptoms such as rhinorrhea, sneezing, and itching when compared with placebo in adults with seasonal allergic rhinitis (17355).
• Amenorrhea. Oral astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One preliminary clinical study shows that taking a liquid decoction containing astragalus 30 grams, dong quai 30 grams, zizyphus 10 fruits, horny goat weed 15 grams, dodder 30 grams, and three slices of ginger, daily in two divided doses for 3 months, can increase menstrual frequency when compared to baseline in patients with amenorrhea (33050). The validity of this finding is limited by the lack of a comparator group.
• Angina. It is unclear if oral astragalus is beneficial for angina. Details: A preliminary clinical trial shows that taking astragalus 20 grams orally three times daily for 2 weeks can improve cardiac output, but not diastolic function, when compared to baseline in patients with angina (33063). The validity of these findings is limited by the lack of a comparator group.
• Anthracycline cardiotoxicity. It is unclear if intravenous astragalus is beneficial for preventing cardiotoxicity due to anthracyclines. Oral astragalus has not been evaluated for this use. Details: A large unblinded clinical study in patients with breast cancer or lymphoma receiving a chemotherapy regimen containing epirubicin shows that intravenous use of astragalus 500 mg daily for 14 days during 2 courses of chemotherapy modestly attenuates the decline in left ventricular ejection fraction (LVEF) and reduces the occurrence of cardiotoxicity when compared with standard care (110479). However, this study was conducted in China, which limits the generalizability of its results.
• Aplastic anemia. It is unclear if intravenous astragalus is beneficial for aplastic anemia. There is insufficient reliable information about the clinical effects of oral astragalus for this condition. Details: Preliminary clinical research in patients 15 years and older with chronic aplastic anemia shows that giving intravenous astragalus in combination with stanozolol 2 mg three times daily produces greater improvements in symptoms and blood cell counts than stanozolol alone. Astragalus was given as 80-120 grams daily for repeated 15-day courses at 7-10 day intervals for at least 4 months (32840).
• Asthma. Oral astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children with mild asthma shows that taking a combination of astragalus, cordyceps, Radix stemonae (Bai Bu), bulbus fritillariae cirrhosae, and Baikal skullcap orally for 6 months does not improve asthma symptoms, measures of lung function, or total steroid use when compared with placebo (32935).
• Beta-thalassemia. Although there has been interest in using oral astragalus for beta-thalassemia, there is insufficient reliable information about the clinical effects of astragalus for this condition.
• Breast cancer. Although there has been interest in using oral astragalus for breast cancer, there is insufficient reliable information about the clinical effects of astragalus for this condition.
• Cervical cancer. Oral astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of 19 clinical trials in adults with cervical cancer who are receiving chemotherapy shows that the use of Chinese herbal medicines containing astragalus increases tumor response (complete and partial responses) and Karnofsky performance score and reduces chemotherapy-associated adverse effects when compared with chemotherapy alone (107479). However, most studies included in the meta-analysis were low-quality, and all studies were conducted in China. Higher quality studies in other geographic locations are needed to confirm these findings. Additionally, it is unclear if any effects are due to astragalus, other ingredients, or the combination.
• Chemotherapy-induced anemia. Oral or intravenous astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of low-quality clinical trials in patients with colorectal cancer shows that oral or intravenous use of traditional Chinese medicine therapies containing astragalus and other ingredients along with conventional chemotherapy reduces the risk of anemia by 51% when compared with chemotherapy alone (102099). It is unclear if these effects are due to astragalus, the other ingredients, or the combination.
• Chemotherapy-induced diarrhea. It is unclear if oral or intravenous astragalus is beneficial for chemotherapy-induced diarrhea. Details: One preliminary clinical study shows that intravenous infusion of astragalus 40 grams in 250 mL of solution, given daily for 21 days during each of four courses of chemotherapy, reduces diarrhea by 59% when compared to chemotherapy alone (32747). Additionally, a meta-analysis of low-quality clinical trials in patients with colorectal cancer shows that oral or intravenous use of traditional Chinese medicine therapies containing astragalus and other ingredients along with conventional chemotherapy reduces the risk of diarrhea by 45% when compared with chemotherapy alone (102099). It is unclear if these effects are due to astragalus, the other ingredients, or the combination.
• Chemotherapy-induced leukopenia. Oral or intravenous astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of low-quality clinical trials in patients with colorectal cancer shows that oral or intravenous use of traditional Chinese medicine therapies containing astragalus and other ingredients along with conventional chemotherapy reduces the risk of thrombocytopenia by 41% when compared with chemotherapy alone (102099). It is unclear if these effects are due to astragalus, the other ingredients, or the combination.
• Chemotherapy-induced nausea and vomiting (CINV). Early research suggests that intravenous astragalus seems to reduce nausea and vomiting associated with chemotherapy use. It is unclear if oral astragalus is beneficial for CINV. Details: A meta-analysis of low-quality clinical research in Chinese patients with advanced non-small cell lung cancer shows that intravenous infusion of astragalus along with platinum-based chemotherapy reduces the risk of vomiting by 38% when compared with platinum-based chemotherapy alone (100698). Another preliminary clinical study shows that intravenous infusion of astragalus 40 grams in 250 mL of solution, given daily for 21 days during each of four courses of chemotherapy, reduces nausea by 36% and vomiting by 50% when compared with chemotherapy alone (32747). Higher quality studies are needed to confirm these results. The use of astragalus in combination with other ingredients for prevention of CINV has also been investigated. A meta-analysis of low-quality clinical trials in patients with colorectal cancer shows that oral or intravenous use of traditional Chinese medicine therapies containing astragalus and other ingredients along with conventional chemotherapy reduces the risk of nausea and vomiting by 44% when compared with chemotherapy alone (102099). It is unclear if these effects are due to astragalus, the other ingredients, or the combination.
• Chemotherapy-induced nephrotoxicity. Oral or intravenous astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of low-quality clinical trials in patients with colorectal cancer shows that oral or intravenous use of traditional Chinese medicine therapies containing astragalus and other ingredients along with conventional chemotherapy does not reduce the risk of nephrotoxicity when compared with chemotherapy alone (102099). The effects of astragalus when used alone are unclear.
• Chemotherapy-related fatigue. It is unclear if intravenous astragalus is beneficial for chemotherapy-related fatigue. There is insufficient reliable information about the clinical effects of oral astragalus for this condition. Details: One clinical study in patients with advanced cancer shows that treatment with an intravenous infusion of a partially purified astragalus extract (PG2, Pharmagenesis), 500 mg three times weekly for 4 weeks during chemotherapy, improves fatigue scores after one week, but not after two and four weeks, when compared with placebo (33034).
• Chronic fatigue syndrome (CFS). Oral astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One preliminary clinical study in adults with CFS shows that taking a 200 mL decoction containing astragalus 30 grams, kudzu 30 grams, codonopsis 15 grams, red sage 10 grams, aizoon stonecrop 15 grams, horny goat weed 10 grams, turmeric 10 grams, and calamus 10 grams, in two divided doses daily for 3 months improves fatigue symptoms when compared to baseline (32920). Another preliminary clinical study shows that taking 1.5 grams of a specific product (Myelophil, Samik Pharmaceutical Company) containing 66% of extracts of astragalus and danshen in a 1:1 ratio twice daily for 4 weeks improves fatigue severity when compared with placebo. However, taking 3 grams of the same product twice daily does not seem to have a benefit (32883). It is unclear if these effects are due to astragalus, the other ingredients, or the combination.
• Chronic kidney disease (CKD). It is unclear if intravenous astragalus is beneficial for CKD. There is insufficient reliable information about the clinical effects of oral astragalus for this condition. Details: A meta-analysis of preliminary clinical research in patients with CKD shows that using astragalus, usually as an injection, along with conventional treatment modestly improves creatinine clearance by 6 mL/min, serum creatinine by 0.25 mg/dL, and hemoglobin levels by 1 gram/dL when compared with conventional treatment alone (90660). However, the studies included in the meta-analysis were of low quality. Also, it is not known if astragalus reduces mortality or attenuates the progression to kidney failure.
• Cirrhosis. Intravenous astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. There is insufficient reliable information about the clinical effects of oral astragalus for this condition. Details: A meta-analysis of results from low-quality clinical studies shows that intravenous injection of a combination of astragalus and danshen for up to 90 days might decrease fibrosis when compared with control in patients with liver cirrhosis (90662). However, it is unclear if this is due to astragalus, danshen, or the combination.
• Colorectal cancer. Oral or intravenous astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of clinical trials in patients with colorectal cancer shows that oral or intravenous use of traditional Chinese medicine therapies containing astragalus and other ingredients along with conventional chemotherapy improves quality of life scores and increases the rate of tumor response by 52% when compared with chemotherapy alone (102099). It is unclear if these effects are due to astragalus, the other ingredients, or the combination.
• Congestive heart failure (CHF). It is unclear if oral or intravenous astragalus is beneficial for CHF. Details: One preliminary clinical study in adults with CHF shows that intravenous infusion of astragalus 60 grams daily for 20 days improves left ventricular ejection fraction (LVEF) and left ventricular end-diastolic volume (LVEDV) when compared with conventional treatment (32755). However, another preliminary clinical study shows that intravenous astragalus 60 grams daily for 28 days in combination with conventional treatment for CHF does not improve LVEF, LVEDV, or left ventricular end-systolic volume when compared with conventional treatment alone (32812). Both of these studies have methodological problems. Other preliminary clinical research shows that taking oral astragalus 2.25-7.5 grams twice daily for 14-30 days in combination with conventional treatment improves cardiac function, LVEF, and walking distance when compared with conventional treatment alone (33018,33022).
• Diabetes. It is unclear if oral or intravenous astragalus is beneficial for diabetes. Details: A meta-analysis of preliminary clinical research in Chinese patients with type 2 diabetes shows that astragalus, given as a daily intravenous injection 40-80 grams or taken orally 40-60 grams daily as an aqueous decoction for up to 4 months, modestly improves fasting and postprandial blood glucose levels when compared to a control group. Oral astragalus seems to improve these outcomes slightly more than intravenous astragalus. Orally, astragalus also seems to improve fasting insulin levels and insulin resistance, although its effect on glycated hemoglobin (HbA1c) is inconsistent. The clinical studies included in this analysis were of low methodological quality and included only Chinese patients, which limits the reliability and generalizability of the results (95909). Some research has evaluated astragalus in combination with other ingredients. One preliminary clinical study in adults with previously untreated type 2 diabetes shows that taking astragalus 210 mg, goldthread 350 mg, and honeysuckle 840 mg three times daily before meals for 3 months does not improve fasting blood glucose, postprandial blood glucose, or HbA1c when compared with placebo, although glucose disposal rate is modestly improved (32925).
• Diabetic nephropathy. It is unclear if intravenous astragalus is beneficial for diabetic nephropathy. Details: Meta-analyses of small, low-quality clinical studies including over 4700 patients shows that adding intravenous astragalus to routine therapy for 2-12 weeks modestly improves blood urea nitrogen, serum creatinine, creatinine clearance, urinary protein, urinary albumin, and serum albumin when compared with routine therapy alone in patients with diabetic nephropathy (33019,102100).
• Diabetic retinopathy. It is unclear if oral astragalus is beneficial for diabetic retinopathy. Details: A meta-analysis of results from preliminary clinical research suggests that taking astragalus-containing products for up to 10 months modestly improves visual acuity and fundus manifestations when compared with control in patients with diabetic retinopathy. However, the included studies had methodological limitations, and the results were heterogeneous (90655).
• Fibromyalgia. Although there has been interest in using oral astragalus for fibromyalgia, there is insufficient reliable information about the clinical effects of astragalus for this condition.
• Gastric cancer. Oral and intravenous astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of 35 randomized, controlled trials involving 2670 patients with advanced gastric cancer shows that taking either intravenous or oral traditional Chinese medicines containing astragalus in conjunction with platinum-based chemotherapy may improve objective response rate, disease control rate, 1-year survival rate, and quality of life, and may also reduce the severity of chemotherapy-associated adverse effects, when compared with chemotherapy alone (107480). The validity of this meta-analysis is limited by potential publication bias, unclear randomization methods, and substantial heterogeneity among the included studies. Additionally, it is unclear if these effects are due to astragalus, other ingredients, or the combination.
• Hearing loss. It is unclear if intravenous astragalus is beneficial for hearing loss. Details: Preliminary clinical research shows that injecting 0.5 mL/kg of solution containing astragalus 2 grams/mL daily for 10 days improves hearing in people with sudden deafness or acute acoustic trauma when compared with a control group (33028,33033).
• Hepatitis B. Although there has been interest in using oral astragalus for hepatitis B, there is insufficient reliable information about the clinical effects of astragalus for this condition.
• HIV/AIDS. Oral astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study shows that taking a combination containing mainly Baikal skullcap root, glossy privet fruit, astragalus root, and Eupolyphaga et polyphage (Ailing granules) 20 grams twice daily for 4 months improves HIV/AIDS symptoms and CD4 cell counts (32824). However, taking a different combination containing licorice, yin chen, white mulberry, astragalus, and safflower orally for 12 weeks is associated with only a slight decline in viral load and no change in CD4 cell counts (32795). The effects of astragalus alone are unclear.
• IgA nephropathy. Although there has been interest in using intravenous astragalus for IgA nephropathy, there is insufficient reliable information about the clinical effects of oral or intravenous astragalus for this condition.
• Lung cancer. Early research suggests that oral or intravenous astragalus seems to increase the effectiveness of platinum-based chemotherapy or radiotherapy in patients with advanced non-small cell lung cancer (NSCLC). Details: One meta-analysis in patients with advanced NSCLC shows that intravenous administration of astragalus along with platinum-based chemotherapy increases the rate of one-year survival by 40% when compared with platinum-based chemotherapy alone (100698). Other meta-analyses in these patients show that use of oral or intravenous astragalus-containing herbal products appears to reduce the risk of death at six months by 42%, at one year by 33%, at two years by 27% to 33%, and at three years by 15% to 24% when compared with platinum-based chemotherapy or radiotherapy alone (15001,90656). However, most studies included in the meta-analyses were low-quality, and all studies were conducted in China. Higher quality studies in other geographic locations are needed to confirm these findings.
• Membranous nephropathy. Oral astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of 48 small, low-quality clinical studies in adults with idiopathic membranous nephropathy conducted in China shows that taking astragalus 20-90 grams per day in combination with a variety of other supplements, in addition to conventional therapy, modestly improves the rate of complete or partial renal remission when compared with conventional therapy (e.g. angiotensin-converting enzyme inhibitors, immunosuppression). Adding astragalus combinations to conventional therapy also modestly reduces proteinuria and serum creatinine (112010). However, the interpretation of these findings is limited by the heterogeneity of the included studies and variable definitions of complete and partial renal remission. Additionally, it is unclear if these effects are due to astragalus, other ingredients, or the combination.
• Menopausal symptoms. Oral astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One preliminary clinical study shows that taking Dang Gui Buxue Tang, an herbal decoction containing astragalus and dong quai extract, 3 grams daily for 6 months does not reduce the incidence of menopausal hot flashes (32857). However, another preliminary clinical study shows that taking Dang Gui Buxue Tang 3-6 grams daily for 12 weeks reduces hot flash frequency by up to 40% and night sweat frequency up to 53% when compared to baseline (90659). Each 1.5 grams of Dang gui Buxue Tang contains extract prepared from dong quai 1.5 grams and astragalus 7.5 grams (90659). Another small clinical study in females with moderate or severe menopausal symptoms shows that taking a tablet containing astragalus and Rubus coreanus extract 1000 mg twice daily for 12 weeks modestly improves symptom and quality of life scores when compared with placebo (110478). However, the validity of these findings is limited by a high rate of study participant discontinuation.
• Myocardial infarction (MI). Although there has been interest in using intravenous astragalus for MI, there is insufficient reliable information about the clinical effects of oral or intravenous astragalus for this purpose.
• Myocarditis. It is unclear if oral or injectable astragalus is beneficial for viral myocarditis. Details: A meta-analysis of 13 mostly small, low-quality clinical studies in adults and children with viral myocarditis shows that astragalus injection may improve the total effective rate and reduce markers of inflammation when compared with conventional treatment (110477). However, most studies included in the meta-analysis were low-quality, dosing was variable, and all studies were conducted in China. Higher quality studies in other geographic locations are needed to confirm these findings. Several clinical studies report improvements in cardiac enzymes, cardiac function, or viral load in peripheral leukocytes with the use of astragalus preparations, but results are inconsistent and the methodological quality of these studies is low (33084,33105,33217,33218,33220,33221,33223). Doses demonstrating benefit include intramuscular astragalus extract, equivalent to 8 grams daily for 3-4 months (33105) and intravenous astragalus extract 40 grams daily for 2 weeks (33218,33221). It is unclear if astragalus speeds recovery or reduces the risk of mortality due to myocarditis.
• Nephrotic syndrome. It is unclear if oral astragalus is beneficial for preventing infections in patients with nephrotic syndrome. Details: A meta-analysis of results from two preliminary clinical studies shows that taking astragalus 7.5-15 grams twice daily for 3-6 months reduces the risk of infection by 38% when compared to control in children with nephrotic syndrome (33036).
• Obesity. Oral astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a combination of astragalus, rhubarb, turmeric, red sage root, ginger, and gallic acid concurrently with a reduced-calorie diet does not improve weight loss when compared with a reduced-calorie diet alone in adults who are overweight or obese (20347).
• Post-stroke fatigue. It is unclear if oral astragalus is beneficial for post-stroke fatigue. Details: A preliminary clinical study shows that taking astralagus extract (Sun Ten Pharmaceutical Co. Ltd.) 2.8 grams three times daily for 28 days improves fatigue and some quality of life measures such as social functioning, role functioning, and physical functioning, when compared with placebo in patients experiencing fatigue following a recent stroke (95908).
• Systemic lupus erythematosus (SLE). It is unclear if intravenous astragalus is beneficial for lupus nephritis. There is insufficient reliable information about the clinical effects of oral astragalus for this condition. Details: A preliminary clinical study in adults with lupus nephritis shows that intravenous infusions of astragalus 40 grams daily for 12 consecutive days monthly for 3 months, in combination with corticosteroids and cyclophosphamide once monthly as an intravenous drip, can improve symptoms, reduce infections, and reduce urinary protein excretion when compared to treatment with corticosteroids and cyclophosphamide alone (32838).
• Tinnitus. It is unclear if intravenous astragalus is beneficial for tinnitus. Details: Preliminary clinical research shows that injecting 0.5 mL/kg of solution containing astragalus 2 grams/mL daily for 10 days reduces tinnitus in patients with acute acoustic trauma when compared to a control group (33028).
• Upper respiratory tract infection (URTI). Although there has been interest in using oral astragalus for URTI prevention, there is insufficient reliable information about the clinical effects of astragalus for this purpose.
• Urinary Tract Infections (UTIs). Oral astragalus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A moderate-size clinical study in females aged 18-45 with uncomplicated UTIs shows that taking a supplement containing astragalus root extract 100 mg, d-mannose, citric acid, dandelion, and prebiotics as a sachet dissolved in water twice daily for 5 days improves complete resolution of UTI symptoms and clearance of bacteriuria at days 6 and 35 when compared with placebo (111757). However, it is unclear if these effects are due to astragalus, other ingredients, or the combination.
• Wound healing. Although there has been interest in using topical astragalus for wound healing, there is insufficient reliable information about the clinical effects of astragalus for this purpose. More evidence is needed to rate astragalus for these uses.

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POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. AHCC 4.5-6 grams daily has been used with apparent safety in clinical trials lasting up to 6 months (22926,30419). Population research identified no safety concerns with the use of AHCC 3 grams daily for up to 9 years (30353,94830).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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POSSIBLY SAFE ...when used orally and appropriately. Agaricus mushroom extract has been safely used in doses up to 1500 mg daily for up to 12 months (15404,15421,94715,94716,94719,94721). A specific agaricus lyophilized powder product (Sen-Sei-Ro Powder Gold, Kyowa Wellness Co., Ltd.) has been safely used in doses up to 5.4 grams daily for 6 months (17185).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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POSSIBLY SAFE ...when used orally and appropriately. Doses of astragalus up to 60 grams daily for up to 4 months have been used without reported adverse effects (32920,33038,95909). ...when used intravenously. Infusion of doses up to 80 grams daily for up to 4 months under the supervision of a medical professional have been used with apparent safety (32811,32812,32828,95909). There is insufficient reliable information available about the safety of astragalus when used topically.

PREGNANCY AND LACTATION:
There is insufficient reliable information in humans. However, astragaloside, a constituent of astragalus, has maternal and fetal toxic effects in animals (32881). Avoid using.

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CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, AHCC might increase levels of drugs metabolized by CYP2D6.  Details In vitro studies suggest that AHCC might induce the CYP2D6 enzyme (30369,30420). This effect has not been reported in humans.

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking AHCC might decrease the effects of immunosuppressant drugs.  Details Data from human, animal, and in vitro studies suggests that AHCC stimulates immune function (30351,30358,30360,30361,30366,30367,30368,30371,30376,30379,30381,30382,30416,30418). Theoretically, this may counteract immunosuppressant drug activity.

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking agaricus mushroom with antidiabetes drugs might increase the risk of hypoglycemia.  Details In one clinical study in patients with type 2 diabetes who are stabilized on conventional oral hypoglycemic agents, 3 of 29 patients taking an agaricus mushroom extract 500 mg three times daily for 12 weeks reported hypoglycemia, compared to one of 29 patients in the placebo group (15421).

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CYCLOPHOSPHAMIDE Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, astragalus might interfere with cyclophosphamide therapy.  Details Evidence regarding the effect of astragalus on immunosuppression caused by cyclophosphamide is conflicting. Some animal research suggests that astragalus reverses cyclophosphamide-induced immunosuppression (3713). However, other animal research shows no effect (418).

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, astragalus might interfere with immunosuppressive therapy.  Details Astragalus seems to stimulate immune function (303,10777). Theoretically, taking astragalus might decrease the effects of immunosuppressive therapy.

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, astragalus might increase levels and adverse effects of lithium.  Details Animal research suggests that astragalus has diuretic properties (15103). Theoretically, due to this diuretic effect, astragalus might reduce excretion and increase levels of lithium.

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General ...Orally, AHCC appears to be well tolerated.
Most Common Adverse Effects:
Orally: Bloating, diarrhea, fatigue, foot cramps, headache, nausea.

Dermatologic ...Orally, AHCC 4. 9 grams has been reported to cause mild itching (30375).

Gastrointestinal ...Orally, AHCC 4. 5-9 grams daily has been reported to cause nausea, diarrhea, and bloating (30365,30375,30419).

Musculoskeletal ...Orally, AHCC 9 grams daily has been reported to cause foot cramps (30365). Orally, AHCC 6 grams daily has been reported to cause difficulty moving hand joints (30416).

Neurologic/CNS ...Orally, AHCC 9 grams daily for 14 days has been reported to cause mild and transient headache (30365).

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General ...Orally, agaricus mushroom is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal discomfort, diarrhea, and nausea.
Serious Adverse Effects (Rare):
Orally: Allergic reactions, hepatotoxicity, interstitial lung disease (ILD).

Gastrointestinal ...In one clinical trial, mild gastrointestinal side effects such as nausea, diarrhea, and abdominal discomfort were reported in 6 of 78 patients taking a specific agaricus powder product , Ltd.) 1.8-5.4 grams orally daily for 60 days. The causal relationship between this agaricus mushroom product and the associated gastrointestinal adverse effect was determined to be possible or probable in each case (17185).

Hepatic ...Three cases of severe hepatotoxicity have been reported in females with ovarian or breast cancer receiving chemotherapy who also took agaricus mushroom supplements. Two of the patients had increases in liver function tests a few days after starting agaricus mushroom, which then progressed rapidly to fatal, fulminant hepatitis. One of these patients was also an asymptomatic carrier of hepatitis B virus. In the third case, liver function improved when agaricus mushroom was stopped, worsened when it was restarted, and then recovered fully when the supplement was stopped permanently (16458).

Immunologic ...An allergic reaction has been reported in a female who took a specific agaricus powder product , Ltd.) 1.8 grams daily by mouth for 2 months. The patient developed an urticarial papular rash which resolved when the product was discontinued (17185). Allergic contact cheilitis was also reported in a patient taking a homemade agaricus mushroom extract orally. The reaction resolved upon discontinuation of agaricus mushroom (94720).

Pulmonary/Respiratory ...There is one case report of interstitial lung disease associated with the use of agaricus mushroom for approximately one month in a male with pancreatic ductal adenocarcinoma being treated with gemcitabine. Drug-induced lymphocyte stimulation test (DLST) was positive for agaricus mushroom extract and not gemcitabine. Pneumonitis improved upon discontinuation of agaricus mushroom (108313).

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General ...Orally and intravenously, astragalus root seems to be well tolerated. Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: A case report raises concerns about liver and kidney cysts with astragalus use.

Cardiovascular ...Orally, astragalus has reportedly been associated with lacunar angina in one clinical trial. However, this may not have been caused by astragalus (17355). In addition, rapid intravenous administration of astragalus has resulted in temporary palpitations (32812).

Dermatologic ...Intravenously, astragalus may cause rash, eczema, and pruritus (33034).

Gastrointestinal ...Orally, astragalus has reportedly been associated with enterocolitis and nausea in one clinical trial. However, these effects may not have been caused by astragalus (17355).

Genitourinary ...Orally, astragalus has reportedly been associated with vulvitis in one clinical trial. However, this effect may not have been caused by astragalus (17355).

Hepatic ...A case of high serum CA19-9 levels and small liver and kidney cysts has been reported for a 38-year-old woman who drank astragalus tea daily for one month. Levels returned to normal after one month, and cysts disappeared after ten months. Both symptoms returned following a resumption of astragalus use. The authors state that astragalus was the likely cause given the temporal relationship (90658).

Neurologic/CNS ...Rapid intravenous administration of astragalus has resulted in temporary dizziness (32812).

Pulmonary/Respiratory ...Orally, astragalus has reportedly been associated with rhinosinusitis and pharyngitis in one clinical trial. However, these effects may not have been caused by astragalus (17355).

Renal ...A case of high serum CA19-9 levels and small liver and kidney cysts has been reported for a 38-year-old woman who drank astragalus tea daily for one month. Levels returned to normal after one month, and cysts disappeared after ten months. Both symptoms returned following a resumption of astragalus use. The authors state that astragalus was the likely cause given the temporal relationship (90658).

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